← Back to Search

Radiation Therapy

SBRT + Surgical Stabilization for Bone Metastases

N/A

Waitlist Available

Led By Maksim Vaynrub, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to tolerate radiation simulation and treatment with immobilization of involved anatomic site

Diagnosis of metastatic cancer with radiologic evidence of skeletal metastases

Must not have

Tumor volume or distribution precluding effective SBRT

Expected skin dose at the operative site ≥9 Gy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a combination of radiation and surgery can effectively treat cancer in the bones, and whether this treatment approach can prevent cancer from returning.

Who is the study for?

This trial is for adults over 18 with cancer that has spread to their bones, who are at risk of bone fractures due to the disease. They must be able to undergo surgery, give informed consent, use effective birth control if needed, and have a life expectancy over 3 months. Excluded are those with prior treatments or surgeries in the affected area, high skin dose risks from radiation, immediate fracture risks, certain autoimmune diseases, active infections or low neutrophil counts.

What is being tested?

The study tests the safety and effectiveness of Stereotactic Body Radiotherapy (SBRT) followed by surgical stabilization within one week on patients with bone metastases. The goal is to see if this treatment prevents cancer from returning to the treated bone area.

What are the potential side effects?

Potential side effects include typical reactions related to radiotherapy such as skin irritation at the treatment site, fatigue, possible pain or discomfort post-treatment. Surgical complications could also occur like infection at the surgery site or issues related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can undergo radiation treatment without moving the affected body part.

Select...

My cancer has spread to my bones, confirmed by scans.

Select...

My treatment targets bones in my arm, leg, or pelvis.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My tumor cannot be effectively treated with focused radiation due to its size or spread.

Select...

The skin at my surgery area is expected to receive a high dose of radiation.

Select...

I have had surgery on the area being considered for the trial.

Select...

My knee area is affected.

Select...

I need surgery soon to fix a bone that's about to break.

Select...

I currently have an infection.

Select...

I have an autoimmune disorder affecting my connective tissues.

Select...

I have had radiation therapy to the area being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

risk of major wound complications

Secondary study objectives

rate of local control

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Preoperative Stereotactic Body Radiotherapy (SBRT)Experimental Treatment1 Intervention

Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction. Active sparing of the intended surgical approach will be incorporated into the radiation plan by creating an avoidance structure. Surgical stabilization will proceed within 1 week of completion of radiotherapy. Pathologic specimens will be obtained intraoperatively via existing surgical access for histologic and molecular analysis. An optional research MRI with perfusion will be performed within 30 days prior to radiation simulation and within one-week after radiation therapy using 3T scanner. If patients receive radiation simulation at a non-MSK Manhattan site, MRI with Perfusion will not be performed.

0 / 12Eligibility criteria met